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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209776
Company: REMPEX

Products on NDA 209776

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VABOMERE	MEROPENEM; VABORBACTAM	1GM/VIAL;1GM/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209776

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2017	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209776Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209776Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209776s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209776Orig1s004ltr.pdf
05/25/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209776s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209776Orig1s003ltr.pdf
07/06/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209776s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209776Orig1s001ltr.pdf

Labels for NDA 209776

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209776s004lbl.pdf
05/25/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209776s003lbl.pdf
07/06/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209776s001lbl.pdf
08/29/2017	ORIG-1	Approval	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf

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